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US set to update PMA (pre-market approval) rule

The US FDA is considering whether to update the regulation that permits companies to use foreign clinical trials results in premarket approval (PMA) applications. The current position of the agency is that it will accept foreign clinical study data (that is not part of an investigational device exemption) if: they conform to the ethical principles contained in the 1989 version of the Helsinki Declaration; or they provide greater protection for humans, to the laws and regulations of the country in which the research was conducted. .

The US FDA is considering whether to update the regulation that permits companies to use foreign clinical trials results in premarket approval (PMA) applications. The current position of the agency is that it will accept foreign clinical study data (that is not part of an investigational device exemption) if: they conform to the ethical principles contained in the 1989 version of the Helsinki Declaration; or they provide greater protection for humans, to the laws and regulations of the country in which the research was conducted. .

But last October the World Medical Association (WMA) revised the Helsinki Declaration, prompting thoughts that the FDA might modify its...

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